AccessGUDID - DEVICE: ARROW (20801902067221)

GUDID

Device Identifier (DI) Information

Brand Name: ARROW
Version or Model: IPN040046
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AK-03000-S
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 20801902067221
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: Single Shot Epidural Anesthesia Kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34842	Epidural anaesthesia set, non-medicated	A collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAZ	Anesthesia conduction kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K770356	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 0 Centimeter

Device Record Status

Public Device Record Key: 3cbde8bd-d733-4297-bbc2-c23132491c9c
Public Version Date: November 13, 2023
Public Version Number: 7
DI Record Publish Date: September 27, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10801902067224	5	20801902067221	2023-11-10	Not in Commercial Distribution	Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(919)544-8000
Email: CS@TELEFLEX.COM

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